Cardiac InflammationGATEDOTANCT06467968
Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication
A study testing Cardiac ECG-gated PET imaging will added in people with Cardiac Inflammation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Inflammation
- What is being tested?
- Cardiac ECG-gated PET imaging will added
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2023to 26 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons who have received complete information on the organization of the research and who have signed the informed consent and:
- Age ≥ 18 years old.
- Having read and understood the information document.
- Affiliated to a social security scheme.
- Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumour.
Who cannot join
- Person with
- Hypersensitivity during previous use of 68Ga-DOTATOC
- Impossibility of performing a PET-CT (patient agitated, confused, etc.).
- History of heart disease,
- Severe arrhythmia that does not allow the PET synchronized with the ECG
- Severe renal insufficiency (GFR <30 ml/min/1.73 m2)
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- Treated with a somatostatin analogue.
- Cushing's syndrome
- Pregnant woman, likely to be or breastfeeding
- Adult subject to a legal protection measure (guardianship, curators, legal safeguard)
- Person of legal age unable to express their consent
- Person deprived of liberty by a judicial or administrative decision
- Person, subject to psychiatric care under articles L. 3212-1 and L. 3213-1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Veronique Roch
Vandœuvre-lès-Nancy, 54511
VERONIQUE ROCH, v.roch@chru-nancy.fr
About this study
Official title: GATED-PET Heart Analysis in Patients Having a Gallium-68--DOTATOC PET/CT Exam for Oncology Indication
Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated.
The hypothesis is that the GATED mode on a Gallium-68-DOTATOC cardiac recording would be able to highlight abnormalities that could be correlated with the age of the patients and their cardiovascular risk factors.
Read the detailed description
People with the selection criteria for the study, coming to the nuclear medicine department in order to benefit from a Gallium-68-DOTATOC PET/CT exam as part of a diagnostic or pre-therapeutic assessment of a neuroendocrine tumor will be offer to participate in the study After sign consent, patients were install in a room to have blood drawn for Troponin Ic, BNP and CRP and after Gallium-68-DOTATOC infusion Gallium-68-DOTATOC PET/CT will be recorded and immediately the cardiac record in Gated mode
- Conditions
- Cardiac Inflammation
- Being tested
- Cardiac ECG-gated PET imaging will added
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac ECG-gated PET imaging will addedOther
Also called blood sample
Blood sample will be used to measure troponin, BNP and CRP . After 68Ga-DOTATOC PET/CT whole body recording, a cardiac ECG-gated PET imaging will added
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumor Receives: Other: Cardiac ECG-gated PET imaging will added |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between the captation of radiotracer and the cardiovascular disease
Measurement of myocardial activity
Measured: 1 day
Secondary outcomes (1)
Relationship between the captation of radiotracer and the troponin value
Correlation between the myocardial activity and the troponin value
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start2 Feb 2023
- Primary completion24 Feb 2027 (estimated)
- Study completion26 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac InflammationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu PERRIN, Central Hospital, Nancy, France
- Investigators
- Mathieu PERRIN, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467968
- Sponsor's protocol ID
- 2022PI008
- Acronym
- GATEDOTA
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2022
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GATED-PET Heart Analysis in Patients Having a Gallium-68--DOTATOC PET/CT Exam for Oncology Indication
- ClinicalTrials.gov ID
- NCT06467968
- Acronym / sponsor ID
- GATEDOTA / 2022PI008
- Conditions
- Cardiac Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 26 May 2027 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated.
The hypothesis is that the GATED mode on a Gallium-68-DOTATOC cardiac recording would be able to highlight abnormalities that could be correlated with the age of the patients and their cardiovascular risk factors.
Detailed description
People with the selection criteria for the study, coming to the nuclear medicine department in order to benefit from a Gallium-68-DOTATOC PET/CT exam as part of a diagnostic or pre-therapeutic assessment of a neuroendocrine tumor will be offer to participate in the study After sign consent, patients were install in a room to have blood drawn for Troponin Ic, BNP and CRP and after Gallium-68-DOTATOC infusion Gallium-68-DOTATOC PET/CT will be recorded and immediately the cardiac record in Gated mode
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Cardiac ECG-gated PET imaging will addedPerson for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persons who have received complete information on the organization of the research and who have signed the informed consent and:
- Age ≥ 18 years old.
- Having read and understood the information document.
- Affiliated to a social security scheme.
- Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumour.
Key exclusion criteria (13 listed)
- Person with
- Hypersensitivity during previous use of 68Ga-DOTATOC
- Impossibility of performing a PET-CT (patient agitated, confused, etc.).
- History of heart disease,
- Severe arrhythmia that does not allow the PET synchronized with the ECG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac ECG-gated PET imaging will addedAlso: blood sampleBlood sample will be used to measure troponin, BNP and CRP . After 68Ga-DOTATOC PET/CT whole body recording, a cardiac ECG-gated PET imaging will added | Other | Patients |
Primary outcome
Relationship between the captation of radiotracer and the cardiovascular disease
Time frame: 1 day
Measurement of myocardial activity
1 secondary outcome
Relationship between the captation of radiotracer and the troponin value
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathieu PERRIN, MD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac ECG-gated PET imaging will added in people with Cardiac Inflammation, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VERONIQUE ROCH, MSc (03 83 15 42 76 ext. +33, v.roch@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between the captation of radiotracer and the cardiovascular disease (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.